MigrainePhase 2NCT00246337

A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

A Phase 2 study testing MK0974 and Rizatriptan in people with Migraine, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Migraine
What is being tested?: MK0974 and Rizatriptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 420 participants
Where: No sites listed yet
Study dates: Nov 2005to May 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial
Patient is in general good health based on screening assessment

Who cannot join

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years

About this study

Official title: A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Conditions: Migraine
Being tested: Comparator: Placebo, MK0974, Rizatriptan
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: PlaceboDrug
Placebo to match assigned treatment arm; one orally-administered dose
MK0974Drug
MK0974 25 mg; one orally-administered dose
MK0974Drug
MK0974 50 mg; one orally-administered dose
MK0974Drug
MK0974 100 mg; one orally-administered dose
MK0974Drug
MK0974 200 mg; one orally-administered dose
MK0974Drug
MK0974 300 mg; one orally-administered dose
MK0974Drug
MK0974 400 mg; one orally-administered dose
MK0974Drug
MK0974 600 mg; one orally-administered dose
RizatriptanDrug
Rizatriptan 10 mg; one orally-administered dose

Study groups in NCT00246337
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. Receives: Drug: Comparator: Placebo
MK0974 25 mg	Experimental	MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 50 mg	Experimental	MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 100 mg	Experimental	MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 200 mg	Experimental	MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 300 mg	Experimental	MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 400 mg	Experimental	MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
MK0974 600 mg	Experimental	MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: MK0974
Rizatriptan 10 mg	Active comparator	Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Receives: Drug: Rizatriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Relief at 2 Hours
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Measured: 2 hours post dose

Secondary outcomes (3)

Pain Freedom at 2 Hours
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
Measured: 2 hours post dose
Sustained Pain Relief
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Measured: 2-24 hours post dose
Sustained Pain Freedom
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Measured: 2-24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005May 2006

First posted31 Oct 2005 (estimated)
Study startNov 2005
Primary completionMay 2006
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00246337
Sponsor's protocol ID: 0974-004
Other IDs: 2005_082
Status last verified: Oct 2015
First submitted: 27 Oct 2005
Last updated: 2 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.
PubMed 17914062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
ClinicalTrials.gov ID: NCT00246337
Acronym / sponsor ID: 0974-004
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 31 Oct 2005 (estimated)
Results: Posted 15 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Comparator: PlaceboPlacebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
MK0974 25 mg	Experimental	Drug: MK0974MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 50 mg	Experimental	Drug: MK0974MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mg	Experimental	Drug: MK0974MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mg	Experimental	Drug: MK0974MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 300 mg	Experimental	Drug: MK0974MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mg	Experimental	Drug: MK0974MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mg	Experimental	Drug: MK0974MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mg	Active comparator	Drug: RizatriptanRizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial
Patient is in general good health based on screening assessment

Key exclusion criteria (5 listed)

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: PlaceboPlacebo to match assigned treatment arm; one orally-administered dose	Drug	Placebo
MK0974MK0974 25 mg; one orally-administered dose	Drug	MK0974 25 mg
MK0974MK0974 50 mg; one orally-administered dose	Drug	MK0974 50 mg
MK0974MK0974 100 mg; one orally-administered dose	Drug	MK0974 100 mg
MK0974MK0974 200 mg; one orally-administered dose	Drug	MK0974 200 mg
MK0974MK0974 300 mg; one orally-administered dose	Drug	MK0974 300 mg
MK0974MK0974 400 mg; one orally-administered dose	Drug	MK0974 400 mg
MK0974MK0974 600 mg; one orally-administered dose	Drug	MK0974 600 mg
RizatriptanRizatriptan 10 mg; one orally-administered dose	Drug	Rizatriptan 10 mg

Primary outcome

Pain Relief at 2 Hours
Time frame: 2 hours post dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.

3 secondary outcomes

Pain Freedom at 2 Hours
Time frame: 2 hours post dose
Sustained Pain Relief
Time frame: 2-24 hours post dose
Sustained Pain Freedom
Time frame: 2-24 hours post dose

Results and safety

Results posted to the registry on 15 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	147	115
MK0974 25 mg	16	14
MK0974 50 mg	18	15
MK0974 100 mg	17	16
MK0974 200 mg	16	12
MK0974 300 mg	54	39
MK0974 400 mg	54	45
MK0974 600 mg	53	40
Rizatriptan 10 mg	45	34

Primary outcome: Pain Relief at 2 Hours

Time frame: 2 hours post dose. Number. Unit: Participants

Measure	Placebo n = 115	MK0974 25 mg n = 14	MK0974 50 mg n = 15	MK0974 100 mg n = 16	MK0974 200 mg n = 12	MK0974 300 mg n = 38	MK0974 400 mg n = 45	MK0974 600 mg n = 40	Rizatriptan 10 mg n = 34
Value	52	5	9	8	5	25	22	27	24

Placebo vs MK0974 300 mg vs MK0974 400 mg vs MK0974 600 mg: p = 0.015, generalized linear model

Population analysed: All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 47 (2.1%)	10 of 47 (21.3%)	Not reported
MK0974 25 mg	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
MK0974 50 mg	0 of 19 (0%)	9 of 19 (47.4%)	Not reported
MK0974 100 mg	0 of 27 (0%)	4 of 27 (14.8%)	Not reported
MK0974 200 mg	0 of 18 (0%)	7 of 18 (38.9%)	Not reported
MK0974 300 mg	0 of 51 (0%)	9 of 51 (17.6%)	Not reported
MK0974 400 mg	0 of 52 (0%)	12 of 52 (23.1%)	Not reported
MK0974 600 mg	0 of 49 (0%)	14 of 49 (28.6%)	Not reported
Rizatriptan 10 mg	0 of 50 (0%)	10 of 50 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17914062Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK0974 and Rizatriptan in people with Migraine, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Relief at 2 Hours (time frame: 2 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00246337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.